RecallDepth

CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.

Company
Medical Components, Inc Dba Medcomp
Recall Initiated
April 11, 2008
Posted
September 16, 2008
Terminated
October 28, 2008
Recall Number
Z-1909-2008
Quantity
100 units
Firm Location
Harleysville, PA

Reason for Recall

kit contains incorrect component

Distribution

The products were shipped to customers in PA and TX.

Lot / Code Info

Lot number MAPA870

Root Cause

Mixed-up of materials/components

Action Taken

The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product.

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